GLW Medical Innovation Quality Policy:

The GLW Way

Patients and their families give every one of our developments a purpose. Every investment has a soul. Every product has a pulse. The ability to improve patients’ lives is a powerful tool, it is the spirit of our company, and it defines our future.

Each of our customers is considered a partner. We focus on creating extraordinary partnerships and helping our partners deliver better care safely and efficiently. Together we can improve patients’ lives across the globe.

Our employees have professional and personal growth opportunities to allow them to meet their career aspirations. Exceptional teamwork will always be at the core of our business, we accept failure as a part of success, and we can achieve the impossible by depending on our team.

We have the power to improve patients’ lives for decades to come. We support a better healthcare system. We are developing future leaders. We will continue to benefit all our stakeholders and shareholders.

And we know that nothing can be better than this.

GLW Quality Management System policies are defined in accordance with the framework of FDA Quality System Regulation (21 CFR Part 820) and ISO 13485.

Quality Management System Qualifications:

GLW established and implemented an ISO 13485 quality system by taking a world-class approach to the design, development, manufacturing, distribution and servicing of our medical devices. ISO 13485 requires accountability, compliance with regulations such as the FDA’s Current Good Manufacturing Practices (CGMP), maintenance of documentation, and traceability of products.

GLW, Inc. is certified by Intertek, a Medical Device Single Audit Program (MDSAP) recognized auditing organization, as conforming to the requirements of:  

• ISO 13485:2016
• Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6)
• Canada: Medical Devices Regulations – Part 1‐ SOR 98/282
• United States: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D), 21 CFR 821

Regulatory Registrations:

GLW products are cleared by FDA under the 510(k) Clearance path. See FDA 510(K) pre-market notification database for more information on the company different 510(k) clearances here.

Unique Device Identifiers (UDI) containing GLW key device identification information with specific GS1 GTIN part numbers are submitted to the FDA and can be found on AccessGUDID database here.

GLW, Inc. Owner/Operator Number: 10058309.

MDSAP Certificate Number: 0159000.